Kornimate/medical-research-clean huggingface dataset:
augmentation study of a computerized treatment for social anxiety disorder

Conditions: Social Anxiety Disorder

Summary: the purpose of this study is to determine whether briefly reactivating a fear memory 10 minutes prior to administering a social anxiety treatment will enhance the durability of treatment effects.

this study examines whether cognitive bias modification of interpretation (cbm-i) for socially anxious individuals can be augmented with the inclusion of a fear memory reactivation prior to administration of cbm. to date, cbm-i generally involves presenting participants with short vignettes that have ambiguous meaning. the ambiguity is resolved by having the subject complete a word stem at the conclusion of the paragraph, resolving the ambiguity in a positive/negative/neutral fashion. cbm attempts to retrain the tendency for socially phobic individuals to adopt negative interpretations of ambiguous events by repeatedly presenting trials resolving in a positive fashion. an inert control can be administered by having the majority of cbm trials resolve in a neutral fashion, without having the vignette end in either a positive or negative fashion. reactivating a fear memory, followed by a short break, purportedly opens a window of several hours during which the fear memory is rendered labile, and so cbm given during this time should show greater durability of effects. however, manipulations given outside of this timeframe will presumably have no increased effects. individuals exhibiting clinical levels of social anxiety, as measured with the 5th edition of the diagnostic and statistical manual of mental disorders (dsm-5) criteria, will be randomly assigned to one of three conditions: (1) fear reactivation administered 10 minutes prior to cbm, (2) fear reactivation administered 12-36 hours prior to cbm, and (3) fear reactivation administered 12-36 hours prior to an inert form of cbm. a variety of measures measuring anxiety, interpretation bias, and cognitions will be repeatedly assessed across the study, including at pretreatment, post treatment, and at one and two week follow up. additionally, several potential moderators of treatment outcome will be assessed prior to engaging in treatment. at two week follow up, participants will also be given a speech stressor task to determine its effect on subsequent interpretation bias.

Eligibility criteria:
inclusion criteria: * ages 18-65 * score of 30 or above on lsas * score of 1.4 or greater on assiq exclusion criteria: * receiving any form of anxiety medication or psychotherapy for anxiety during the past 3 months * scoring above a "1" on item 9 of the bdi-ii (presence of serious suicidal ideation)

Keywords: social anxiety disorder social phobia reconsolidation cognitive bias modification interpretation bias
zostavax™ in patients on chronic/maintenance corticosteroids (v211-017) (completed)

Conditions: Herpes Zoster

Summary: the purpose of the study was to assess the safety, tolerability, and immunogenicity of zostavax™ in patients receiving chronic/maintenance corticosteroids.


Eligibility criteria:
inclusion criteria: * varicella-history positive, herpes zoster (hz)-history negative patients * 60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period) * all females enrolling must be postmenopausal exclusion criteria: * patients with a history of hypersensitivity reaction to gelatin or neomycin * prior receipt of varicella or zoster vaccine; prior history of herpes zoster * immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period * receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment * known immune deficiency that is caused by a medical condition * any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses * concomitant use of antiviral therapy * a history of alcohol abuse or recreational drug use
bacterial analysis of kidney stones removed by percutaneous nephrolithotomy

Conditions: Urolithiasis

Summary: the aim of this research is to use a controlled laboratory setting to determine whether bacteria isolated from kidney stones of patients play a role in the formation of non-infectious kidney stones. it is well known that struvite stones are associated with active bacterial infection, however the role of bacteria in the formation of non-infection stones (like calcium oxalate) is not well characterized and there are theories that bacteria are involved in the making of these stones.

kidney stone disease is common, affecting nearly 10% of the population with increasing prevalence and increasing cost associated to treat this disease. while struvite stones (composed of magnesium, ammonium and phosphate crystals) have been associated with the presence of infection, the association between bacteria and non-infection stones is not well characterized. previous studies have found bacteria present in stones of patients without active infection and with negative pre-operative urine tests. there are various compositions of kidney stones, including calcium oxalate, calcium phosphate, struvite and uric acid, with calcium oxalate being the most common. it is well known that struvite stones are associated with active infection, however the role of bacteria in the formation of other types of kidney stones, including calcium oxalate, is not well understood. the investigators hypothesize that bacteria present in the urinary tract of patients without active infection have the ability to facilitate calcium oxalate crystal formation by providing a surface for stones to grow. an understanding of the role of bacteria in the formation of non-infection stones could help prevent stone formation by altering the bacteria present within patients to decrease or eliminate their risk of kidney stone disease.

Eligibility criteria:
inclusion criteria: * over the age of 18 * diagnosed with or have a high index of suspicion of having a kidney stone and scheduled to undergo percutaneous nephrolithotomy. * medically fit for definitive surgical management of stone exclusion criteria: * those with medical comorbidities preventing them from safely undergoing definitive surgical therapy. * patients who are unable to provide informed consent. * 18 years old or younger * diagnosed with an infection stone * urinary tract infection within 3 months before date of operation * antibiotic use within 3 month before date of operation

Keywords: kidney stones renal calculi
preoperative pulmonary systolic pressure and outcome after non-cardiac surgery:threshold analysis

Conditions: Pulmonary Hypertension

Summary: the linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. this study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery.

the linear or nonlinear relationship of pulmonary systolic pressure and cardiovascular and kidney outcome after non-cardiac surgery is unknown. this study is to explore the relationship of the two and try to identify the possible threshold of pulmonary systolic pressure for major cardio-vascular events after non-cardiac surgery. patients with preoperative cardio-echogram under going non-cardiac surgery were collected. the postoperative major cardiovascular, cerebral and kidney events were also identified and collected. other data including peri-operative information and surgeries and anesthesia data were gathered. logistic regression models were built and selected. independent risk factors relative to postoperative major cardiovascular and cerebral events were screened and identified. odds ratio, relative risk and relative risk ratio of varies dichomitus cut points were calculated, trend breakpoint were identified, propensity score analysis were also done for causal inference.

Eligibility criteria:
inclusion criteria: non-cardiac surgery patients with preoperative echocardiography records exclusion criteria: electronic records missing or peri-operative data missing

Keywords: pulmonary hypertension, major cardiovascular event, non-cardiac surgery,threshold
[124i]fiau pet-ct scanning in diagnosing osteomyelitis in patients with diabetic foot infection

Conditions: Diabetic Foot Infection

Summary: this protocol will evaluate the sensitivity and specificity of \[124i\]fiau as a diagnostic imaging agent for the detection of osteomyelitis in patients with diabetic foot infection.


Eligibility criteria:
inclusion criteria: 1. male and female patients \>/= 18 years on the day of signing consent. 2. a diagnosis of diabetes mellitus, type i or ii, as evidenced either by hba1c\>6.5% or receipt of antidiabetic medication at time of enrollment. 3. ability to provide informed consent 4. an inframalleolar ulcer of perfusion, extent/size, depth/tissue loss, infection and sensation (pedis) grade 2 or 3. at the discretion of the investigator, patients with pedis grade 4 infections may be included if they are sufficiently stable. 5. for females of childbearing potential, a negative urine pregnancy test on the day of dosing. 6. for females of childbearing potential, a willingness to use 2 methods of contraception for 30 days after receiving \[124i\]fiau. 7. ability to return for all study assessments. 8. clinically euthyroid, or on stable thyroid replacement therapy. exclusion criteria: 1. patients who ar unable to comply with study requirements. 2. indication, in the opinion of the principal investigator for urgent surgery that would preclude the time needed for pet-ct scanning, or clinical instability that precludes pet-ct scanning. 3. history of an inherited mitochondrial disorder (eg. leber's hereditary neuropathy, neuropathy, ataxia, retinitis pigmentosa and ptosis \[narp\], myoneurogenic gastrointestinal encephalopathy \[mngie\], myocolonic epilepsy with ragged red fibers \[merff\] and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome \[melas\]) 4. alanine aminotransferase (alt)\>5x upper limit of normal (uln) or aspartate aminotransferase (ast) \>5x uln. 5. body mass that exceeds the rating of the ct table. 6. hypersensitivity to iodine. 7. pregnant or breast-feeding. 8. any condition that would put the patient at unreasonable risk in the opinion of the investigator.
efficacy of rapamycin in the treatment of cervico-facial lymphatic malformations

Conditions: Lymphatic Malformation; Pediatric

Summary: to evaluate the efficacy of rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. rapamycin is administered oral for a 6 month period. the success rate is determined by volume reduction superior to 1/5e of the initial volume measured by mri, impact on qol and reduction of bleeding in case of mucosal involvement.


Eligibility criteria:
inclusion criteria: * patient from 0 to 18 years of age, presenting with poly-cystic suprahyoid or mediastinal lymphatic. * with chronic pain or functional respiratory or swallowing impairment with a cds score \< 8 * curative treatment is not possible or associated with a high risk of morbidity ,mortality and functional and cosmetic impairment * karnofsky score (\> 10 years of age) or lansky score (≤10 years of age) \> 50% * biology * neutrophils count≥1.0 x 109/l * platelets count ≥ 100 x 109/l * hemoglobin ≥ 8 g/dl * bilirubin ≤ 1,5 uln * transaminases \< 2,5 uln * serum albumin ≥ 2 g/dl. * ldl cholesterol \<160 mg/dl * triglycerides \< 150 mg/dl * negative test of pregnancy if relevant * social security affiliation * at least 2 months after a previous procedure on the malformation exclusion criteria: * non-respect of inclusion criteria * other immunosuppressive therapy or long-term general corticosteroid therapy without a 28-day washout period * renal failure * liver failure * digestive disease leading to rapamycin malabsorption * uncontrolled or severe infectious disease * patients requiring treatment interfering with cyp3a4 isoenzyme (rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin) or inhibiting cyp3a4 isoenzyme's activity (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin, diltiazem, verapamil, nicardipine, clotrimazole, fluconazole , troleandomycin, bromocriptine, cimetidine, danazol, protease inhibitors) -patients requiring treatment by cisapride and metoclopramide * concomitant administration of mtor inhibitor * peanuts or soya allergy * impossibility to receive informed consent * absence of social security affiliation * refusal to sign consent * ongoing pregnancy or breastfeeding * refusal to participate

Keywords: cervico-facial rapamycin
study evaluating desvenlafaxine succinate sustained-release (dvs sr) in the treatment of child and adolescent outpatients with major depressive disorder

Conditions: Depression; Major Depressive Disorder

Summary: the primary purpose of this study is to test the safety and tolerability of single ascending doses of desvenlafaxine succinate sustained-release (dvs sr) in both child and adolescent outpatients with major depressive disorder. this study will also characterize the pharmacokinetic profile of dvs sr in children and adolescents with major depressive disorder.


Eligibility criteria:
inclusion criteria: * male or female outpatient between 7 and 17 years of age at baseline who meet diagnostic and statistic manual of mental disorders, fourth edition, text revision criteria for major depressive disorder. * children's depression rating scale --revised (cdrs-r) score greater than 40 at the screening and study day -1 (baseline) visits and clinical global impressions scale--severity (cgi-s) score of greater than or equal to 4 at the screening and study day -1 (baseline) visits. * depression of at least moderate severity with symptoms for at least 1 month before screening and that could, in the investigator's opinion, respond to therapy with antidepressant(s) alone (without concomitant psychotherapy). * other inclusion criteria apply. exclusion criteria: * history or current evidence of a medical condition known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs; history or presence of any other medical condition that might confound the study or put the study participant at greater risk during participation; known hypersensitivity to venlafaxine. * history of suicide attempt or gesture in which the intent was suicide or serious self-harm or acute suicidality to such a degree that precaution against suicide must be exercised. * current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a diagnosis of bipolar disorder or psychotic disorder or current (within 12 months before baseline) generalized anxiety disorder, panic disorder, social anxiety disorder, or attention deficit hyperactivity disorder (adhd) if considered by the investigator to be primary (causing a higher degree of distress or impairment than mdd) or presence (within 12 months before baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, or narcissistic) as assessed during the psychiatric evaluations or history or presence of mdd with psychotic features. * other exclusion criteria apply.

Keywords: mdd child adolescent pharmacokinetic outpatient pediatrics depressive disorder major
feasibility of remote measures and assessments in deep brain stimulation for parkinson's disease (forma-dbs)

Conditions: Parkinson Disease

Summary: this is an observational pilot study to assess the feasibility of remote functional assessments of gait, balance, and functional mobility via a telemedicine platform enabled via the abbott infinity devices. the clinical care of the participant will not be changed based on the remote functional assessments.

this is a single-center, non-randomized pilot observational study to explore the feasibility and tolerability of remotely assessing gait speed, functional mobility and balance measures in patients with parkinson's disease experiencing medication-refractory tremor, motor complications and/or dyskinesias undergoing initiation of deep brain stimulation therapy. this study explores the feasibility of remotely performing and collecting functional assessments of gait, balance and mobility in the setting of programming deep brain stimulation (dbs). ten participants who are deemed surgical candidates for receiving dbs for parkinson's disease under standard of clinical care processes (neuropsychological testing, neurology consultation and neurosurgery consultation) and have opted for the abbott dbs system will be enrolled in the study and undergo the pre-surgical and post-surgical visits. a pre-operative in-clinic visit will take place approximately 28 days (day -42) prior to surgical dbs electrode lead implantation. an at-home assessment will take place within 14 days (day -28) of this baseline visit, still prior to surgical dbs electrode lead implantation. participants will receive care as usual including their first post-operative clinic visit for initial programming (day 28), just like standard of care for dbs patients.

Eligibility criteria:
inclusion criteria: * patients with with parkinson's disease, as confirmed by the treating investigator, providing written consent to the clinical study * participants have been determined by the treating investigator as candidates for dbs * participants who have opted to have dbs with the remote-programming capable platform * have internet connection at home or wherever participants will be receiving care remotely and be able to participate in telemedicine visits and remote programming exclusion criteria: * has already had prior surgical lesioning or deep brain stimulation therapy * meets criteria for parkinson's disease dementia in the opinion of the treating investigator * does not have capacity for consent as judged by the treating investigator * scores less than 24 on the montreal cognitive assessment (moca) at standard of care dbs screening, indicating, at least, mild cognitive impairment

Keywords: deep brain stimulation (dbs) remote monitoring subthalamic nucleus (stn) internal globus pallidus (gpi) patient global impression of change (pgic) activities balance confidence scale (abc) movement disorders society unified parkinson's disease rating scale (mds-updrs)
effect of a low calorie diet containing nuts on systemic and vascular inflammation

Conditions: Cardiovascular Risk Factor

Summary: accumulating evidence from prospective observational studies and a large clinical trial suggests that nut intake lowers the risk of cardiovascular disease (cvd). tree nuts are rich in unsaturated fats, soluble ﬁber, antioxidants, and phytosterols. the purpose of this study is to compare the effects of low calorie diets with a mixture of nuts in comparison with low calorie diets in improving inflammatory markers in patients with stable coronary artery disease.

a randomized placebo controlled clinical trial will be conducted in modares hospital in tehran, iran. after review of the inclusion and exclusion criteria and explanation of the design of the study, written consent form will be completed. the participants are 66 eligible patients, aged 35-70 years. intervention group will be received low calories diets as well as 20 percent of daily calories from mixed nuts (peanuts, pistachio and almond) and control group will be received low calories diets for 8 weeks. fasting blood sample will be taken to measure inflammatory markers (interleukine-6 \[il-6\] and interleukine-10 \[il-10\] and c-reactive protein \[crp\]).

Eligibility criteria:
inclusion criteria: * patients with at least one of the cardiovascular risk factors (hypertension, hyperlipidemia, diabetes mellitus) * patients with coronary artery disease * willing to participation in the study exclusion criteria: * َchronic kidney disease stage 3-5 * any change in disease treatment plan such as change in type and dose of lipid lowering drugs or surgical operation
obesity and goal-directed intraoperative fluid therapy

Conditions: Obesity

Summary: the purpose of the study is to compare non-obese patients (bmi≤ 30 kg/m2)versus obese patients (bmi\> 30 kg/m2) in regard of their respective needs for intraoperative fluid therapy during laparoscopic surgery. specifically the investigators will test the hypothesis that subcutaneous tissue oxygenation (psqo2)is increased in obese patients when fluid management is optimized by means of esophageal doppler monitoring compared to obese patients undergoing standard fluid management. furthermore the investigators will test the hypothesis that psqo2 is decreased in obese patients undergoing conventional fluid therapy compared to non-obese patients when fluid management is optimized. thus the investigators assume that psqo2 is similar in obese and non-obese patients when fluid management is optimized in both groups.

hemodynamic stability and normovolemia are critical determinants of tissue perfusion and oxygenation. adequate tissue oxygenation is essential to maintain normal physiologic functions and to reduce complications, such as wound infections. fat tissue is relatively hypoperfused and, therefore, poorly oxygenated. subcutaneous tissue oxygenation in the obese is thus critically low and even supplemental oxygen only slightly increases subcutaneous oxygenation.it is likely that poor subcutaneous oxygenation in the obese surgical patients results in part from inadequate intraoperative fluid replacement. it remains unknown how to hydrate obese surgical patients best. the most physiologic approach for perioperative fluid replacement is now thought to be goal-directed management, using stroke volume as the treatment parameter.

Eligibility criteria:
inclusion criteria: * non-obese (bmi≤ 30kg/m2) and obese patients (bmi \> 30 kg/m2) * undergoing laparoscopic elective fundoplication or elective bariatric surgery exclusion criteria: * decompensate heart failure * documented coronary artery disease * renal insufficiency * severe chronic obstructive pulmonary disease * symptoms of infection or sepsis * esophageal disease (excepting gastro-esophageal reflux without any other esophageal alteration).

Keywords: obesity esophageal doppler monitoring tissue oxygen tension